MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CENTURION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number	8065752181
Medical Device Problem Code	Inability to Irrigate (1337)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that irrigation failure occurred during cataract with intraocular lens implant surgery.The surgery was completed after replacing the pak with another one.There was no patient harm.
Additional Manufacturer Narrative
A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.Current tracking indicates no adverse trend for this lot for this event.The returned sample was visually inspected and functionally tested.Both irrigation and aspiration luers were intact.Flare shape was observed in the blue socket fitting at the aspiration tubing insertion end.The sample was tested using a calibrated console with the current software revision.The sample could be recognized, and the service data could be retrieved from the console.Sample passed functionality.The root cause of the customer's complaint could not be established since the returned sample met specifications.No contributing factors could be identified that could cause the reported complaint.After the investigation of this complaint, it has been determined that this sample met specifications.Therefore, no action will be taken at this time.Based on our current tracking, there are no adverse trends for this reported complaint.Quality assurance will continue to monitor customer complaints via the complaint review meetings and will take action for any future occurrences as is deemed necessary.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION SURGICAL PROCEDURE PAK
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 19296312
• Report Number: 1644019-2024-01010
• Device Sequence Number: 5855448
• Product Code: LRO
• UDI-Device Identifier: 00380657521814
• UDI-Public: 00380657521814
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: 8065752181
• Device Lot Number: 167RA6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown